Syringes and injector systems with collapsible cartridges

ABSTRACT

A syringe system ( 20 ) includes an elongated shell ( 30 ), a pressure member ( 80 ) slidable disposed within the elongated shell ( 30 ), and a collapsible cartridge ( 100 ). The Collapsible cartridge ( 100 ) is inserted within the elongated shell ( 30 ), and collapses as the pressure member ( 30 ) is advanced within the elongated body ( 30 ) to pressurize fluid within the collapsible cartridge ( 100 ). The collapsible cartridge ( 100 ) preferably further includes a passage ( 130 ) through which the fluid passes when pressurized by the pressure member ( 80 ).

This application claims the benefit of Provisional application Ser. No.60/109,476 filed Nov. 23, 1998.

FIELD OF THE INVENTION

The present invention relates to syringe systems and injector systemsand, more particularly, to medical syringe systems and injector systemswith collapsible cartridges for containing and pressurizing theinjection fluid.

BACKGROUND OF THE INVENTION

Syringes have been used in the medical arts for many decades now. Ingeneral, all syringes include a barrel or chamber into which a fluid tobe injected is charged. The syringes also include a reciprocatingplunger that is advanced to pressurize the fluid within the barrel forinjection and retracted to draw fluid into the barrel.

In recent years, a number of injector-actuated syringes and poweredinjectors for use in medical procedures such as angiography, computedtomography, ultrasound and MRI have been developed. For example, U.S.Pat. No. 4,006,736 discloses an apparatus for injecting fluid into thevascular system of a human being or an animal. Likewise, U.S. Pat. No.4,677,980 discloses an angiographic injector and syringe wherein thedrive member of the injector can be connected to, or disconnected from,the syringe plunger at any point along the travel path of the plungervia a releasable mechanism. Further, U.S. Pat. No. 5,383,858 discloses anon-pressure-jacketed front-loading syringe and injector system.

Although numerous advances have been made in syringe technology,numerous problems persist. For example, plungers used in currentsyringes typically comprise an elastomeric plunger cover that forms asliding seal with the inside of the syringe barrel, usually requiring alubricant to reduce frictional forces. Although maintenance of sterilityis of the utmost importance in many medical procedures, lubricants usedin connection with the plunger may come into contact with andcontaminate the injection medium. Moreover, the inside wall of thesyringe barrel may become contaminated during the reciprocating motionof the plunger.

In addition to maintaining sterility, it is also very important toinject a predetermined amount of material in many medical procedures.Often, if the wrong amount of injection medium is drawn into the syringeand injected, the procedure must be redone. In certain cases, disposablesyringes are supplied in a “prefilled” state to assist in ensuringsterility and a controlled injection volume. However, current prefilledsyringes are rather difficult to produce and require specializedmaterials.

It is very desirable to develop syringes that reduce or eliminate theproblems discussed above and other problems associated with currentsyringes.

SUMMARY OF THE INVENTION

In one embodiment, the present invention provides a syringe systemincluding an elongated shell, a pressure member slidably disposed withinthe elongated shell, and a collapsible cartridge. The collapsiblecartridge is inserted within the elongated shell. The collapsiblecartridge collapses as the pressure member is advanced within theelongated body to pressurize fluid within the collapsible cartridge. Thecollapsible cartridge preferably further includes a passage throughwhich the fluid passes when pressurized by the pressure member.

The collapsible cartridge is preferably fabricated from a pliant orcollapsible film suitable to withstand pressures commonly experienced inmedical procedures such as angiography, computed tomography, ultrasoundand MRI when the collapsible cartridge is pressurized within the shell.The shell preferably acts as a pressure jacket to assist in withstandingsuch pressures.

The pressure member of the syringe system may include an attachmentmechanism to form an attachment with a drive member of a poweredinjector, as known in the art. For example, the attachment mechanism maybe formed in the manner shown and described in U.S. Pat. Nos. 4,677,980and 5,383,858. Alternately, however, in the event that the cartridge isprefilled with fluid, the pressure member may be designed to be“push-only,” thereby not requiring an attachment mechanism to allowretraction of the pressure member for, for example, filling thecartridge with fluid.

The present invention also provides a method of injecting a fluid into apatient including the steps of: loading a collapsible cartridge forcontaining the fluid into an elongated shell, the collapsible cartridgecomprising a passage through which the fluid passes when pressurized bya pressure member slidably disposed within the shell; and advancing thepressure member to collapse the collapsible cartridge and therebypressurize the fluid within the collapsible cartridge.

The collapsible cartridges of the present invention may be prefilledwith injection fluid before loading thereof into the shell of thesyringe system or may be filled with injection fluid thereafter.

The syringe systems of the present invention are very simple andinexpensive to manufacture. For example, they greatly simplify andreduce the cost of manufacturing a disposable, prefilled syringe systemthat may be used with a single patient in a single injection procedure.The syringe systems of the present invention may be manually operated orinjector-actuated, depending on the application. Moreover, the syringesystems of the present invention eliminate the need for a plunger thatforms a seal with the inner wall of the syringe barrel. Contaminationconcerns arising from the use of elastomeric plunger covers andassociated lubricants are thereby eliminated.

BRIEF DESCRIPTION OF THE DRAWINGS

Other aspects of the invention and their advantages will be discernedfrom the following detailed description when read in connection with theaccompanying drawings, in which:

FIG. 1A illustrates a cross-sectional view of one embodiment of asyringe system of the present invention.

FIG. 1B illustrates a cross-sectional view of the syringe system of FIG.1A in which the pressure member has been advanced.

FIG. 1C illustrates a cross-sectional view of the syringe system of FIG.1A in which a seal has been provided to prevent air from entering intothe area between the pressure member and the barrel of the shell.

FIG. 2A illustrates a perspective view of the collapsible cartridge ofthe embodiment of FIG. 1.

FIG. 2B illustrates a perspective view of another embodiment of acollapsible cartridge of the present invention.

FIG. 3A illustrates a cross-sectional view of another embodiment of asyringe system and an injector system of the present invention.

FIG. 3B illustrates a cross-sectional view of the syringe system of FIG.3A in which the pressure member has been advanced.

FIG. 3C illustrates a cross-sectional view of another embodiment of asyringe system of the present invention having a collapsible cartridgethat is preformed or prestressed to collapse in a controlled manner.

FIG. 4 illustrates a side view of a pressure member for use with thecollapsible cartridges of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

A first embodiment of a syringe system 20 of the present invention isillustrated in FIGS. 1A-1C. Syringe system 20 preferably includes arelatively rigid outer shell or jacket 30. Shell 30 preferably includesan elongated, generally cylindrical barrel portion 40. Shell 30preferably further includes a forward abutment wall 50 at a forward endof barrel portion 40.

Syringe system 20 also includes a collapsible cartridge 100 as furtherillustrated in FIG. 2A. Collapsible cartridge 100 preferably includes agenerally cylindrical collapsible film 105, which may be formed frompolyethylene (PET), polypropylene (PP) or polyurethane (PU).

At a rearward end of collapsible film 105, a first, relatively rigid endportion 110 may be sealingly attached to collapsible film 105. At aforward end of collapsible film 105, a second, relatively rigid endportion 120 may be sealingly attached to collapsible film 105.Collapsible film 105 and end portions 110 and 120 form a collapsiblechamber into which a fluid to be injected into a patient can be charged.

Second end portion 120 preferably comprises a. passage 130 therethrough.Passage 130 is preferably in fluid connection with a tapered dischargeor injection region 140. Pressurized injection fluid is discharged froma discharge tip 150. Tapered injection region 140 preferably extendsthrough a forward, annular passage 70 formed in abutment wall 50.

Collapsible cartridge 100 is preferably loaded within barrel portion 30from a rearward end 60 of barrel portion 30. Discharge tip 150 ofcollapsible cartridge 150 is preferably provided with a sealing capmember (not shown) to retain the injection fluid within collapsiblecartridge 100 for shipment and storage of collapsible cartridge 100.Discharge tip 150 may for example comprise a luer connection forconnection to tubing (after removal of the sealing cap member) as knownin the art.

Syringe system 20 preferably further comprises a pressurizing member orpressure member 80 slidably disposed in barrel 40 of shell 30. Pressuremember 80 is advanced forward to pressurize the fluid within collapsiblecartridge 100.

Unlike the case of current syringes incorporating plungers, there is norequirement to form a seal between pressure member 80 and the insidewall of barrel portion 40 and, therefore, no sliding force on the insidewall of barrel portion 40. The use of lubricants is thus eliminated.Moreover, pressure member 80 never comes into contact with the fluidwithin collapsible cartridge 100 and need not even contact the innerwall of barrel portion 40, thereby greatly reducing the risk of fluidcontamination. The fluid is pressurized by reducing the volume ofcollapsible cartridge 100 upon forward motion of pressure member 80.

In the embodiment of FIGS. 1A-1C, as pressure member 80 is advancedforward within barrel portion 40, collapsible film 105 preferably evertson itself. During such advancement of pressure member 80, collapsiblefilm 105 is held rigidly against shell 30 and against pressure member 40by pressure in the injection fluid. As pressure member 40 advancesforward, collapsible film 105 moves from being in contact with shell 30and everts to be in contact with pressure member 80.

Another embodiment of a collapsible cartridge 100′ is illustrated inFIG. 2B. In this embodiment, collapsible cartridge 100′ comprises acollapsible film 105′ that is preferably sealed at the rearward endthereof with a seam or seal 165 and at a forward end thereof with seamor seal 165′ of film 105′. Another seam or seal (not shown) may extendlongitudinally or axially down the side of collapsible cartridge 100′.The interior of collapsible cartridge 100′ is preferably in fluidconnection with a tapered discharge or injection region 140′ via apassage 130′. As described above, pressurized injection fluid isdischarged from a discharge tip 150′.

As clear to one skilled in the art, prefilled, disposable, collapsiblecartridges (as, for example, illustrated in FIGS. 2A and 2B) are easilyinserted into shell 30. In some cases, however, it may be desirable tofill the collapsible cartridge with injection fluid after insertionthereof and, potentially, to reuse the collapsible cartridge formultiple injection procedures.

In the case of the syringe system 20 as illustrated in FIGS. 1A and 1B,however, collapsible cartridge 100 or 100′ would be difficult to fillwith injection fluid after insertion thereof in shell 30. In thatregard, if pressure member 80 were attached to (or formed integrallywith) rearward end 110 of collapsible cartridge 100 and drawn rearward,collapsible film 105 would collapse.

In the embodiment of FIG. 1C, a generally cylindrical seal 155 ispositioned at the rearward end of shell 30 to provide a sealingengagement between pressure member 80 and shell 30. Because seal 155prevents air from entering the space between pressure member 80 andbarrel portion 40 of shell 30, when pressure member 80 is drawn rearwardinjection fluid can be drawn into collapsible cartridge 100 or 100′.Seal 155 can be very simple in design as it needs to sustain onlyapproximately 1 atmosphere of pressure, in a preferred embodiment.

As used herein to describe syringe system 20 and collapsible cartridges100 and 100′, the terms “axial” or “axially” refer generally to an axisA around which syringe system 20 and collapsible cartridge 100 arepreferably formed (although not necessarily symmetrically therearound)The terms “proximal” or “rearward” refer generally to an axial directiontoward the end of syringe system 20 opposite discharge tip 150 or 150′.The terms “distal” or “forward” refer generally to an axial directiontoward discharge tip 150 or 150′ of syringe system 20. The term “radial”refers generally to a direction normal to axis A.

Preferably, the syringe systems of the present invention are used inconnection with a powered injector 310 (see FIG. 3A) as known in theart. Powered injectors suitable for use in the present invention aredisclosed in U.S. Pat. Nos. 4,677,980, 5,383,858, 5,779,675 and5,300,031, the disclosures of which are incorporated herein byreference. Alternately, however, the syringe systems of the presentinvention can be readily applied to hand-held or manually-operatedsyringes.

Syringe molds/designs and injector systems currently in use arerelatively easily retrofitted for use with the collapsible cartridges ofthe present invention. In that regard, such syringes can act as theshell or jacket for the collapsible cartridges of the present inventionwith only minor modification. In FIGS. 3A and 3B, for example, aninjector system 300 and a syringe system 220 are illustrated. Syringesystem 220 comprises a shell 230 that is very similar to many syringescurrently in use with front-loading powered injectors, such as theinjector and syringe system shown and described in U.S. Pat. No.5,383,858, the contents of which are hereby incorporated by reference.

As known in the art, shell/syringe 220 preferably comprises anelongated, generally cylindrical body or barrel section 240. A generallyfrusto-conical transition region 250 is preferably positioned at theforward end of cylindrical body 240. Collapsible cartridge 100′ isillustrated within the interior of shell 230 as loaded through rearwardshell end 260. Tapered injection region 140′ extends through a passage270 formed at the forward end of frusto-conical transition region 250.

As illustrated in FIGS. 3A through 4, pressure member 80′ may comprisecapture member 85 to preferably form a releasable connection with apiston member 320 of a powered injector 310, as known in the art fromU.S. Pat. Nos. 4,677,980 and 5,383,858 and PCT Publication No. WO98/20920, the contents of which are hereby incorporated by reference.

In the embodiment of FIGS. 3A and 3B, the space between pressure member80′ and the inner wall of barrel member 240 is too small to allow theeverting movement of collapsible film 105′ as discussed in connectionwith the embodiments of FIGS. 1A through 1C. In the embodiment of FIGS.3A and 3B, collapsible film 105′ collects at the rear of collapsiblecartridge 100′ as pressure member 80′ is advanced and pressurizedinjection fluid is discharged from discharge tip 150′. Once again,however, there is no need for the formation of a sealing engagement (oreven contact) between pressure member 80′ and the inner wall of barrelportion 240 to pressurize the fluid within collapsible cartridge 100′.Pressure member 80 can, however, form a seal with barrel portion 40adequate to sustain approximately 1 atmosphere of pressure to enablefilling of collapsible cartridge 100′ upon retraction of pressure member801.

For applications in which injection volume need not be preciselycontrolled, collapsible film 105′ can be allowed to collect at therearward end thereof in an uncontrolled “scrunch” as illustrated in FIG.3B. In cases in which it is desirable to more accurately control thevolume of fluid injected, the collapsible film can be preformed orprestressed to give some order to the scrunch. In FIG. 3C, for example,collapsible film 105″ has been preformed in the shape of a bellows toprovide an orderly collapse thereof upon advance of pressure member 80′.

It should be appreciated that the syringe systems of the presentinvention may be configured in various ways and as appropriate for theapplication. The embodiments described above are to be considered in allrespects as being illustrative of the invention, and not restrictive.The scope of the invention is indicated by the following claims ratherthan by the foregoing description. All changes which fall within themeaning and range of equivalency of the claims are to be embraced withintheir scope.

What is claimed is:
 1. A syringe system comprising: a shell; a pressuremember slidably disposed within the shell; a collapsible cartridgeadapted to be inserted within the shell, the collapsible cartridgeoperable to collapse as the pressure member is advanced within the shellto pressurize fluid contained within the collapsible cartridge, thecollapsible cartridge comprising a passage through which the fluidpasses when pressurized by the pressure member; and a seal disposedbetween the pressure member and the shell, the seal operable to allowthe cartridge to be filled with fluid when the pressure member isretracted to draw fluid into the collapsible cartridge.
 2. The syringesystem of claim 1 wherein the pressure member comprises an attachmentmechanism.
 3. The syringe system of claim 2 wherein the attachmentmechanism is operable to form an attachment with a drive member of apowered injector.
 4. The syringe system of claim 1 wherein the seal isgenerally cylindrical.
 5. The syringe system of claim 1 wherein the sealis positioned at a rearward end of the shell.
 6. The syringe system ofclaim 1 wherein the collapsible cartridge comprises a pliant filmsuitable to withstand pressures commonly experienced in medicalprocedures while pressurized within the shell.
 7. The syringe system ofclaim 1 wherein the collapsible cartridge is filled with the fluid priorto insertion of the collapsible cartridge within the shell.
 8. Thesyringe system of claim 1 wherein the pressure member is adapted to bemanually-actuated.
 9. The syringe system of claim 1 wherein thecollapsible cartridge comprises a bellows to allow the cartridge tocollapse in an orderly fashion.
 10. The syringe system of claim 1wherein the collapsible cartridge is adapted to evert upon itself withinthe shell.
 11. A cartridge for use in a shell, the cartridge comprising:a pressure member slidably disposed within the shell; a collapsiblemember adapted to be inserted within the shell, the collapsible memberoperable to collapse as the pressure member is advanced within the shellto pressurize fluid contained within the collapsible member, thecollapsible member comprising a passage through which the fluid passeswhen pressurized by the pressure member; and a seal disposed between thepressure member and the shell, the seal operable to allow thecollapsible member to be filled with fluid when the pressure member isretracted to draw fluid into the collapsible member.
 12. The cartridgeof claim 11 wherein the pressure member comprises an attachmentmechanism.
 13. The cartridge of claim 12 wherein the attachmentmechanism is operable to form an attachment with a drive member of apowered injector.
 14. The cartridge of claim 11 wherein the seal isgenerally cylindrical.
 15. The cartridge of claim 11 wherein the seal ispositioned at a rearward end of the shell.
 16. The cartridge of claim 11wherein the collapsible member comprises a pliant film suitable towithstand pressures commonly experienced in medical procedures whilepressurized within the shell.
 17. The cartridge of claim 11 wherein thecollapsible member is filled with the fluid prior to insertion of thecollapsible member within the shell.
 18. The cartridge of claim 11wherein the pressure member is adapted to be manually-actuated.
 19. Thecartridge of claim 11 wherein the collapsible member comprises a bellowsto allow the member to collapse in an orderly fashion.
 20. The cartridgeof claim 11 wherein the collapsible member is adapted to evert uponitself within the shell.
 21. A method of injecting a fluid into apatient, the method comprising: providing a collapsible cartridge forinsertion into a shell, the collapsible cartridge comprising a passagethrough which the fluid passes from the collapsible cartridge to thepatient; providing a pressure member for pressurizing the fluid placedwithin the collapsible cartridge for injection into the patient;providing a seal disposed between the pressure member and the shell, theseal operable to allow the cartridge to be filled with fluid when thepressure member is retracted to draw fluid into the collapsiblecartridge; inserting the collapsible cartridge into the shell; andadvancing the pressure member to collapse the collapsible cartridge andthereby pressurize the fluid within the collapsible cartridge forinjection into the patient.
 22. The method of claim 21, furthercomprising retracting the pressure member to fill the collapsiblecartridge with fluid.
 23. The method of claim 21, further comprising:removing the collapsed cartridge from the shell; and inserting a secondcollapsible cartridge into the shell.
 24. The method of claim 21 whereinthe pressure member is manually advanced.
 25. A fluid injectionapparatus comprising: a housing; a drive member disposed within thehousing; and a syringe system operably associated with the housing andthe drive member, the syringe system comprising a shell operablyassociated with the housing, a pressure member operable to be engaged bythe drive member and slidably disposed within the shell, a collapsiblecartridge adapted to be inserted within the shell and operable to beengaged by the pressure member, the collapsible cartridge operable tocollapse as the pressure member is advanced by the drive member withinthe shell to pressurize fluid within the collapsible cartridge, thecollapsible cartridge comprising a passage through which the fluidpasses when pressurized by the pressure member, and a seal disposedbetween the pressure member and the shell, the seal operable to allowthe cartridge to be filled with fluid when the pressure member isretracted to draw fluid into the collapsible cartridge.
 26. The fluidinjection apparatus of claim 25 wherein the pressure member and thedrive member comprise mating elements of an attachment mechanism. 27.The fluid injection apparatus of claim 26 wherein the attachmentmechanism allows the drive member to retract the pressure member withinthe shell.
 28. The fluid injection apparatus of claim 25 wherein theseal is positioned at a rearward end of the shell.
 29. The fluidinjection apparatus of claim 25 wherein the collapsible cartridgecomprises a pliant film suitable to withstand pressures commonlyexperienced in medical procedures while pressurized within the shell.30. The fluid injection apparatus of claim 25 wherein the collapsiblecartridge is filled with the fluid prior to insertion of the collapsiblecartridge within the shell.
 31. The fluid injection apparatus of claim25 wherein the pressure member is adapted to be manually-actuated. 32.The fluid injection apparatus of claim 25 wherein the collapsiblecartridge comprises a bellows to allow the cartridge to collapse in anorderly fashion.
 33. The fluid injection apparatus of claim 25 whereinthe collapsible cartridge is adapted to evert upon itself within theshell.